Abstract

Background Five years of prospective clinical trials confirm that paclitaxel drug-coated balloons (DCB) is safe and effective to treat femoropopliteal artery disease. A recent meta-analysis of heterogenous trials of paclitaxel-based balloons and stents reported they are associated with increased mortality and higher doses are linked to higher mortality from 2-5 years.

Objectives: Determine if there is a correlation between paclitaxel exposure and mortality by conducting an independent patient-level meta-analysis of 1,980 patients with up to 5-year follow-up.

Methods Data from four independently-adjudicated prospective studies of DCB (n=1837) and uncoated percutaneous transluminal angioplasty (PTA; n=143) were included. Extensive analyses of baseline, procedure, and follow-up data of individual patients were performed to explore correlations with long-term mortality. Time to survival by paclitaxel dose tercile was analyzed with adjustment of inverse probability weighting to correct baseline imbalances and study as random effect. Endpoint analyses by treatment were adjusted for study as random effect.

Results There was no statistically significant difference in all-cause mortality between DCB and PTA through 5 years (9.3% vs 11.2%, p=0.399). No deaths were adjudicated by an independent clinical events committee as device-related. A survival analysis stratified nominal paclitaxel dose by low, mid, and upper terciles; mean doses were 5,019.0 μg, 10,007.5 μg, and 19,978.2 μg. There was no statistically significant difference in all-cause mortality between the three groups through 5 years (p=0.700).

Conclusions This independent patient-level meta-analysis demonstrates that paclitaxel DCBs are safe. There is no correlation between any level of paclitaxel exposure and mortality.

Condensed Abstract A recent meta-analysis of heterogenous trials of paclitaxel-based balloons and stents reported they are associated with increased long-term mortality. Data from 4 independently-adjudicated prospective studies of DCBs (n=1837) and PTA (n=143) were included in this patient-level analysis. There was no statistically significant difference in all-cause mortality between DCB and PTA through five years (9.3% vs 11.2%, p=0.399). A survival analysis stratifying paclitaxel dose found no statistically significant difference in all-cause mortality through five years (p=0.700). Paclitaxel DCBs are safe. There is no correlation between any level of paclitaxel exposure and mortality.

Footnotes

Funding: Data was transferred for independent analysis to The Baim Institute for Clinical Research, formerly HCRI (Boston, Massachusetts). This analysis was funded by Medtronic.

Disclosures

Schneider is a member of the advisory board for Medtronic, Abbott, and Boston Scientific and a consultant for Surmodics, Silk Road Medical, Medtronic, Cardinal, CSI, and Profusa. He is a Chief Medical Officer for Intact Vascular and Cagent.

Laird is a member of the advisory board at Abbott Vascular and consults for Abbott Vascular, Bard, Boston Scientific, and Medtronic.

Doros is a full-time employee of the Baim Institute for Clinical Research.

Gao is a full-time employee of the Baim Institute for Clinical Research.

Toolbox

Thank you for your interest in spreading the word about JACC: Journal of the American College of CardiologyNOTE: We request your email address only as a reference for the recipient. We do not save email addresses.

Your Email *

Your Name *

Send To *

Enter multiple addresses on separate lines or separate them with commas.